Sirturo

Adult Dosing .

Dosage forms:  TAB: 20 mg, 100 mg

Restricted Distribution in US

[1-800-526-7736 for more info]

tuberculosis, pulmonary

[multi-drug resistant]

Dose: 400 mg PO qd x2wk, then 200 mg PO 3x/wk x22wk; Info: admin. by directly observed tx; give 3x/wk doses at least 48h apart; part of multi-drug regimen; see pkg insert for missed dose recommendations; give w/ food

[multi-drug resistant, tx-intolerant or nonresponsive (off-label)]

Dose: 400 mg PO qd x2wk, then 200 mg PO 3x/wk x24wk; Alt: 200 mg PO qd x8wk, then 100 mg PO qd x18wk; Info: give w/ pretomanid and linezolid; admin. by directly observed tx; give 3x/wk doses at least 48h apart; see pretomanid pkg insert for missed dose and D/C recommendations; may cont. beyond 26wk; give w/ food

[extensively drug resistant (off-label)]

Dose: 400 mg PO qd x2wk, then 200 mg PO 3x/wk x24wk; Alt: 200 mg PO qd x8wk, then 100 mg PO qd x18wk; Info: give w/ pretomanid and linezolid; admin. by directly observed tx; give 3x/wk doses at least 48h apart; see pretomanid pkg insert for missed dose and D/C recommendations; may cont. beyond 26wk; give w/ food

renal dosing

[see below]

mild-moderate impairment: no adjustment; severe impairment: not defined, caution advised, consider monitoring bedaquiline levels

HD/PD: not defined, caution advised, consider monitoring bedaquiline levels

hepatic dosing

[see below]

Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined, weigh risk/benefit

Peds Dosing .

Dosage forms:  TAB: 20 mg, 100 mg

Restricted Distribution in US

[1-800-526-7736 for more info]

tuberculosis, multi-drug resistant

[5 yo and older, 15-29 kg]

Dose: 200 mg PO qd x2wk, then 100 mg PO 3x/wk x22wk; Info: for pts w/ pulmonary infection; admin. by directly observed tx; give 3x/wk doses at least 48h apart; part of multi-drug regimen; see pkg insert for missed dose recommendations; give w/ food

[5 yo and older, >30 kg]

Dose: 400 mg PO qd x2wk, then 200 mg PO 3x/wk x22wk; Info: for pts w/ pulmonary infection; admin. by directly observed tx; give 3x/wk doses at least 48h apart; part of multi-drug regimen; see pkg insert for missed dose recommendations; give w/ food

renal dosing

[see below]

mild-moderate impairment: no adjustment; severe impairment: not defined, caution advised, consider monitoring bedaquiline levels

HD/PD: not defined, caution advised, consider monitoring bedaquiline levels

hepatic dosing

[see below]

Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined, weigh risk/benefit